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It is all there on their website under intellectual property - list of patents and trademarks.
Registered to Avacta. Not sure how I found it, but I found a page of Avacta registrations and trademarks and this is the latest one.
Excel spreadsheet
SD Biosensor is Indian, Innova product is made in China, Healgen is owned by Zhejiang Orient Gene Biotech Co.,LTD/China.
3 rapid tests have been evaluated, SD Biosensor, was one and 2 names I did not recognise.
Someone sent a link to Condor/Raptor update, which I have been trying to find, if anyone else can remember it.
Searching I found this link to Raptor/SD Biosensor training video
https://www.youtube.com/watch?v=N-6N9BUFfgA&feature=youtu.be
Avacta, as the manufacturer, is validating, performing the clinical validation to support the product claims. PHE is evaluating to confirm that they agree with the manufacturer's claims.
If Avacta place consumer products on the market, they will CE mark them through a notified body as self test, and according to the agreement Medusa will distribute.
If the government wants to use them for mass testing and providing them directly, Avacta will not be placing them on the market, the government will be taking that responsibility and providing full instructions for use/possibly even public information tv. The product is not CE marked.
I raised this because I was surprised that they were so specific calling it point of care test, but actually they are contracted to Medusa for consumer test.
Then rereading the blurb, they have definitely nailed their clours to the mast
Quote
- a saliva based point-of-care rapid test intended for screening of large populations to diagnose the COVID-19 coronavirus infection,
They are focussed on their key markets.
I think that I was just surprised that the Avacta website was so specific in describing point of Care rapid antigen test. Actually the agreement with Medusa19 is for them to distribute self tests direct to consumer, so we will get there
In the EU there is a regulatory difference between a point of Care test and a self test.
The point of Care test has to be administered by a professional who should understand sufficiently to perform the test and interpret the result.
For the majority of diagnostic productS once the manufacturer Is satisfied that it complies with all safety/performance and regulatory requirements can apply the CE mark themselves. If you look at 5e medusa Ifu/instructions for use you can see it states that it is for professional use only or words to that effect and there is just a CE mark
A self test product has to have additional user trials and the safety/performance and regulatory requirements have to be reviewed by a notified body. If you look at a pregnancy ifu (be careful how you do it) it will state for self test and the CE mark will have the notified body underneath it.
I believe that this will be the only difference between the Avacta poc and self test - After the additional requirements, there will be different packaging and instructions. You can sell self test products for point of Care, but it is illegal to see Poc tests to lay persons.
I have not looked for a while, but I thought I would follow upon the job vacancy posted below. Yes they are still advertising the same/similar posts for Assay Scientist among others, but the whole website has been revamped.
I am a bit concerned that they are actually describing a point of Care rapid antigen test and hope that this is only phase 1 and they will obtaining CE marking for consumer test.
I don’t think anybody knows.
The number of cases go up, but mainly among the young, so they are not needing hospitalisation. Now more transmission in the community so Even with social distancing and masks etc, more 40-50 year olds are being affected, so hospitalisation will go up.
We were moving towards would you feel confident to visit the theatre, now we are back to whether we should feel confident to visit granny.
Somebody managed to get access to Saturn Pass pre-launch. Any chance of them finding AffiDx?
I say that!!!
But now track and trace are sending people from Bridgwater/other places to Rhondda Cynon Taff (currently in lockdown) to be tested!
Point of care test is generally a simple test which can be used by a trained/ professional person who may not use it very often.
The same simple format could be used for consumer test, but the consumer test (for CE marking) has to have addition lay person trials to confirm that the test instruction are easy to understand and interpret for lay persons. They also have to go through notified body review to approve CE marking.
Lateral flow tests would be example of simple tests for consumer use but a lot of manufacturers have not put them for notified body review. It is illegal to sell professional tests for consumer/self tests
Medusa is trying very hard not to call it an antibody test. It is very misleading and unprofessional
@ Cares4Shares & MrsShares
Joint research - great stuff
Thats right sit tight and don’t let the missus hear that or she’ wup your •••se.
With all the earlier ups and downs in the share price, we found out who had the cojones in our household and it wasn’t MrAlchemyst.
Aside from Avacta and this BB, this is the only other reference I have seen to Adeptrex and BAMS for Covid 19 testing. I can only find info on the US website. I don’t know if there is a Uk distributor for these tests Also their products appear to be more research than IVD. I don’t know who will be selling their use, in the Uk, Eu or Us.
The Avacta test mentioned in this report is the BAMS test not LFT